Staley, Helen, McCallum, Iain and Bruce, J. (Julie) (2012) Postoperative tamoxifen for ductal carcinoma in situ. Cochrane Database of Systematic Reviews (10). doi:10.1002/14651858.CD007847.pub2

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Abstract

Background

Ductal carcinoma in situ (DCIS) is a non-invasive carcinoma of the breast. The incidence of DCIS has increased substantially over the last twenty years, largely as a result of the introduction of population-based mammographic screening. The treatment of DCIS tumours involves surgery with or without radiotherapy to prevent recurrent DCIS and invasive carcinoma. However, there is clinical uncertainty as to whether postoperative hormonal treatment (tamoxifen) after surgery confers benefit in overall survival and incidence of recurrent carcinoma.

Objectives

To assess the effects of postoperative tamoxifen in women having local surgical resection of DCIS.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), the Cochrane Breast Cancer Group's Specialised Register, and the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) on 16 August 2011.

Selection criteria

Published and unpublished randomised controlled trials (RCTs) and quasi-randomised controlled trials comparing tamoxifen after surgery for DCIS (regardless of oestrogen receptor status), with or without adjuvant radiotherapy.

Data collection and analysis

Two authors independently assessed trial quality and extracted data. Statistical analyses were performed using the fixed-effect model and the results were expressed as relative risks (RRs) or hazard ratios (HRs) with 95% confidence intervals (CIs).

Main results

We included two RCTs involving 3375 women. Tamoxifen after surgery for DCIS reduced recurrence of both ipsilateral (same side) DCIS (HR 0.75; 95% CI 0.61 to 0.92) and contralateral (opposite side) DCIS (RR 0.50; 95% CI 0.28 to 0.87). There was a trend towards decreased ipsilateral invasive cancer (HR 0.79; 95% CI 0.62 to 1.01) and reduced contralateral invasive cancer (RR 0.57; 95% CI 0.39 to 0.83). The number needed to treat in order for tamoxifen to have a protective effect against all breast events is 15. There was no evidence of a difference detected in all cause mortality (RR 1.11; 95% CI 0.89 to 1.39). Only one study, involving 1799 participants followed-up for 163 months (median) reported on adverse events (i.e. toxicity, mood changes, deep vein thrombosis, pulmonary embolism, endometrial cancer) with no significant difference between tamoxifen and placebo groups, but there was a non-significant trend towards more endometrial cancer in the tamoxifen group.

Authors' conclusions

While tamoxifen after local excision for DCIS (with or without adjuvant radiotherapy) reduced the risk of recurrent DCIS (in the ipsi- and contralateral breast), it did not reduce the risk of overall mortality.

Item Type:	Journal Item
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Journal or Publication Title:	Cochrane Database of Systematic Reviews
Publisher:	John Wiley & Sons Ltd.
ISSN:	1469-493X
Official Date:	17 October 2012
Dates:	Date Event 17 October 2012 Published
Number:	10
DOI:	10.1002/14651858.CD007847.pub2
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access

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